WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations

Jerome Amir Singh, Sonali Kochhar, Jonathan Wolff, Caesar Atuire, Anant Bhan, Ezekiel Emanuel, Ruth Faden, Prakash Ghimire, Dirceu Greco, Calvin Ho, Suerie Moon, Ehsan Shamsi-Gooshki, Aissatou Touré, Beatriz Thomé, Maxwell J. Smith, Ross E.G. Upshur

Research output: Contribution to journalReview articlepeer-review

Abstract

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

Original languageEnglish (US)
Pages (from-to)2140-2149
Number of pages10
JournalVaccine
Volume40
Issue number14
DOIs
StatePublished - Mar 25 2022

Keywords

  • Placebo-controlled trials
  • Research ethics
  • Standard of care
  • Standard of prevention
  • Trial designs

ASJC Scopus subject areas

  • General Veterinary
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases
  • Molecular Medicine
  • General Immunology and Microbiology

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